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5 Amendments of Maria Veronica ROSSI related to 2023/0131(COD)

Amendment 1120 #
Maria Veronica ROSSI, Gianna GANCIA
Proposal for a regulation
Article 70
Orphan medicinal products addressing a 1. An orphan medicinal product shall be considered as addressing a high unmet medical need where it fulfils the following requirements: (a) there is no medicinal product authorised in the Union for such condition orwhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement; (b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population. 2. A medicinal product for which an application has been submitted in accordance with Article 13 of [revised Directive 2001/83/EC] shall not be considered as addressing a high unmet medical need. 3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and the authorities or bodies referred to in Article 162.Article 70 deleted high unmet medical need
2023/11/21
Committee: ENVI
Amendment 1170 #
Maria Veronica ROSSI, Gianna GANCIA
Proposal for a regulation
Article 71 – paragraph 2 – point a
(a) nineten years for orphan medicinal products other than those referred to in points (b) and (c);
2023/11/21
Committee: ENVI
Amendment 1173 #
Maria Veronica ROSSI, Gianna GANCIA
Proposal for a regulation
Article 71 – paragraph 2 – point b
(b) ten years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;deleted
2023/11/21
Committee: ENVI
Amendment 1210 #
Maria Veronica ROSSI, Gianna GANCIA
Proposal for a regulation
Article 71 – paragraph 3
3. Where a marketing authorisation holder holds more than one orphan marketing authorisations for the same active substance, those authorisations shall not benefit from separate market exclusivity periods whose duration is outlined in paragraph 2. The duration of theeach market exclusivity period shall start from the date when the firstcorresponding orphan marketing authorisation was granted in the Union.
2023/11/21
Committee: ENVI
Amendment 1220 #
Maria Veronica ROSSI, Gianna GANCIA
Proposal for a regulation
Article 72
1. The periods of market exclusivity referred to in Article 71, paragraph 2, points (a) and (b), shall be prolonged by 12 months, where the orphan marketing authorisation holder can demonstrate that the conditions referred to in Article 81(2), point (a), and Article 82(1) [of revised Directive 2001/83/EC] are fulfilled. The procedures set out in Articles 82(2) to (5) [of revised Directive 2001/83/EC] shall accordingly apply to the prolongation of market exclusivity. 2. The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition. Such a prolongation may be granted twice, if the new therapeutic indications are each time for different orphan conditions. 3. The orphan medicinal products which benefit from the prolongation of market exclusivity referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC]. 4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.Article 72 deleted Prolongation of market exclusivity
2023/11/21
Committee: ENVI
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